BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASSO¿ 2515 VARIABLE CIRCULAR MAPPING CATHETER

    MDR report key: 3060209 · Received April 16, 2013

    Report

    Report Number
    9673241-2013-00104
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 25, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    DRF
    PMA / PMN Number
    K031161
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND IT VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PERFORMING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, THE LASSO VARIABLE CATHETER WAS TRAPPED IN THE MITRAL VALVE RIGHT AFTER THE TRANSEPTAL PUNCTURE. THE PHYSICIAN TRIED FOR AT LEAST THREE HOURS TO RELEASE THE CATHETER FROM THE VALVE BUT WAS UNSUCCESSFUL. THE PROCEDURE TURNED INTO OPEN HEART SURGERY AND THE SURGEON CUT THE CATHETER TO RELEASE IT TO MINIMIZE THE RISK OF THE MITRAL VALVE DAMAGE. THE MITRAL VALVE HAD A SMALL REPAIR. UPON REQUEST, ADDITIONAL INFORMATION WAS PROVIDED ON THE EVENT. THE CATHETER HAD TO BE CUT BY THE SURGEON IN THREE PARTS AND A SMALL REPAIR OF THE MITRAL VALVE WAS PERFORMED. ONLY A SMALL MITRAL VALVE INSUFFICIENCY WAS DETECTED IN AN ECHO AFTER A FEW DAYS FROM THE OPEN HEART SURGERY. THE PHYSICIANS OPINION ON THE CAUSALITY OF THE EVENT WAS THAT IT WAS POSSIBLY DEVICE AND POSSIBLY PROCEDURE RELATED. PATIENT IS OBESE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162377 LASSO¿ 2515 VARIABLE CIRCULAR MAPPING CATHETER CATHETER, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1237-01-S 15719382L

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| L| R